Natus Neurology Inc Recall 93969
Description: TENSIVE Conductive Adhesive Gel, REF 016-401600
Natus Neurology Inc Recall 93969 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1305-2024 |
| Event ID | 93969 |
| Event Description | TENSIVE Conductive Adhesive Gel, REF 016-401600 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| Quantity | 80 units |
| Recall Reason | Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Number A0623009. They have received five complaints. These customers reported that the gel is too thick, is discolored (darker than usual), and in one instance, patients reported irritation after procedures using the gel. |
| Device Classification | 20240327 |
| Device Code Info | UDI/DI 00855683006333, Lot Numbers: A0623009 |
| Center Classification Date | 20240319 |
| Recall Initiation Date | 20240207 |
| Recalling Firm | Natus Neurology Inc |
| Initial Notification | Letter |
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